Treatment Trials

125 Clinical Trials for Various Conditions

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RECRUITING
A Mobile Health (mHealth) Strategy for Improving Blood Pressure Control Among Adult Hypertensive African Americans
Description

The purpose of this study is to test the proof-of-concept for adding a novel mHealth application, USeeBP, to the established UChicago Medicine Ambulatory Medicine Remote-Patient Monitoring (UCM-RPM) Hypertension Management Program in a population of African American adults with poorly controlled hypertension.

RECRUITING
A Study of Blood Pressure Control During Cancer Treatment
Description

The purpose of this study to find out whether an intensive approach to treating high blood pressure during breast cancer treatment is safe and more effective than standard blood pressure treatment at lowering blood pressure levels and the risk of cardiotoxicity in patients with cancer. Other studies have shown lowering blood pressure improves the health of patients. However, these studies have not included people with cancer. The PROTECT trial is testing a treatment strategy regarding intensive versus standard SBP goals, and is not testing specific medications.

RECRUITING
Improving Blood Pressure Control Among Food Insecure Hypertensive Adults
Description

The overall objective of this project is to assess the feasibility, acceptability, and appropriateness of adapted community health worker (CHW)-led implementation strategies designed to improve intake of fruits and vegetables and reduce BP among patients with hypertension experience food insecurity.

Conditions
COMPLETED
Preparing a Food Is Medicine Intervention to Promote Healthy Eating and Blood Pressure Control
Description

Hypertension and obesity are both major risk factors for cardiovascular disease (CVD), a leading cause of death for Black women in the United States. The investigators propose examining the feasibility and acceptability of the 12-week RN-CHeFRx (Real Nourishment and Cooking Healthy Food is Rx) intervention - grocery delivery, cooking classes, and nutrition education - for Black women with hypertension and obesity to improve nutritious eating habits and blood pressure control.

RECRUITING
Improving Blood Pressure Control in Stroke Patients by Increasing Access to a Home Blood Pressure Monitor
Description

The goal of this clinical trial is to learn whether providing teaching with a low-cost device can help to improve blood pressure, health outcomes, patient self-efficacy without exacerbating inequity between advantaged and disadvantaged patients. The main question\[s\] it aims to answer are: 1. Does providing a free home blood pressure cuff improve control of hypertension? 2. Does providing a free home blood pressure cuff have a greater impact on control of hypertension in disadvantaged populations? 3. Does improved control of home blood pressure decrease adverse patient outcomes? Participants will be asked to * Take their blood pressure at home and records the results * Participate in follow-up phone calls from investigators at at 3 and 6 months Researchers will compare patients provided with home blood pressure monitors to those who are provided with routine education

ENROLLING_BY_INVITATION
Video-based Intervention to Address Disparities in Blood Pressure Control After Stroke
Description

The purpose of this study is to examine the impact of a multidisciplinary telehealth-based model of outpatient stroke care on blood pressure control following stroke, and further, to evaluate its impact on racial disparities in post-stroke blood pressure control.

Conditions
COMPLETED
Improving Blood Pressure Control Through the myBPmyLife mHealth Application
Description

This study is enrolling eligible participants that have high blood pressure. Reducing dietary salt intake and engaging in regular physical activity is known to decrease blood pressure in people with hypertension. This trial will determine whether a smartwatch and a mobile health application, which together deliver notifications, can increase activity levels and reduce salt intake for people with high blood pressure. All study activities will be completed online or via a mobile medical application. Participants will not have any face-to-face visits with the study team.

Conditions
RECRUITING
Implementation of Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control in Minimize Cognitive Decline
Description

The study will test a multifaceted strategy for implementing an intensive blood pressure intervention protocol targeting systolic BP \<120 mmHg on cognitive decline in racial minority and low-income hypertensive patients in primary care. The proposed study will generate urgently needed data on effective, adoptable, and equitable intervention strategies to reduce blood pressure-related cognitive decline in low- income and minority populations. If proven effective, the implementation strategy for intensive blood pressure reduction could be adapted and scaled up in diverse primary care settings to prevent cognitive decline and clinical dementia.

WITHDRAWN
Clevidipine vs Placebo or Standard of Care for Dyspnea and Blood Pressure Control in AHF
Description

The purpose of this study is to evaluate dyspnea improvement and other parameters of efficacy and safety in acute heart failure (AHF) patients receiving an intravenous (IV) infusion of clevidipine in comparison to standard of care (SOC) and placebo.

COMPLETED
Helping Hypertension Patients to Interpret Blood Pressure Readings and Motivate Blood Pressure Control
Description

Hypertension is a major risk factor for cardiovascular disease, and a leading cause of death worldwide. Only about 50% of hypertension patients have good blood pressure control, perhaps because they find it hard to understand their blood pressure readings. The investigators will evaluate ways to help hypertension patients to interpret their blood pressure readings and motivate blood pressure control. Aim 1: Based on existing communications, the investigators will create 3 blood pressure communications: (A) a basic table showing only the normal blood pressure range, which is often used in clinical practice and online communications about blood pressure, but may make it hard to interpret numbers outside of the normal range, potentially undermining behavior change intentions; (B) an enhanced table showing how combinations of diastolic and systolic blood pressure reflect normal, elevated and hypertension ranges, from the American Heart Association; (C) an enhanced graph to be adapted from Blood Pressure UK to show the same color-coded ranges as the enhanced table, with diastolic blood pressure on the x-axis and systolic blood pressure on the y-axis. Aim 2: : Among 650 diagnosed hypertension patients recruited through the University of Pittsburgh Medical Center (UPMC) Pitt+Me Patient Registry, the investigators will evaluate whether being presented with the enhanced table or graph (vs. basic table) affects patients' self-reported blood pressure measurement (as averaged across two measurements taken at the time of the survey at least 1 minute apart, as per directions of the American Heart Association), and improves interpretations of these two blood pressure readings and of hypothetical blood pressure readings, as well as behavior change intentions. Aim 3: The investigators will examine whether Aim 2 findings vary by health literacy, age, and SES.

Conditions
COMPLETED
The Impact of a Resistance Training Intervention on Blood Pressure Control in Older Adults With Sarcopenia
Description

Current prevention and treatment of high blood pressure (BP) in sarcopenia, by non-pharmacological approaches remain limited and are far from optimal. This randomized control intervention pilot study will provide new evidence of the unexplored relationship between muscle strength and high BP in sarcopenia, and experimentally test the effects of an evidence-based progressive resistance training intervention on BP, while also examining reversibility to identify muscle strength as a non-pharmacological target for BP control in older sarcopenic adults.

COMPLETED
Telehealth Intervention for Improved Blood Pressure Control With Targeted Incentives
Description

Hypertension is the leading risk factor for cardiovascular disease, global mortality, and ranks third among the causes of disability. Treatment of hypertension is relatively straightforward, but patient adherence to long-term self-care strategies is problematically low. Three important behaviors that individuals can adhere to in order to help lower their BP are 1) Taking medications as prescribed by a physician, 2) Monitoring BP at home, and 3) Limiting dietary sodium intake. Adherence to these behaviors is problematic and currently ranges from 25% to 50%; the present Phase I STTR study is aimed at addressing the behavioral barriers for adherence to these three activities with the help of mobile technology. In particular, this STTR will develop and test an incentive program delivered through a mobile health app to increase adherence to prescribed BP control regimens and precipitate reduction in BP.

COMPLETED
Technology-based Intervention and Positive Psychological Training for Blood Pressure Control in African Americans
Description

The purpose of this pilot study is to evaluate the effects of a theoretically-derived technology-based intervention (called TechSuPPorT) and its associated neurological mechanisms for hypertension self-management in African Americans. The investigators will compare two intervention arms in this study, the Technology-Based Component Only arm (comparison group) and the TechSuPPorT arm (intervention group) in 20 African Americans with uncontrolled hypertension. We aim to: 1. Determine whether there are differences in blood pressure (BP), health-related quality of life (HRQoL), and psychological health (affective well-being, depressive cognitions, anxiety) betweenTechSuPPorT and the Technology-based Component only arm. 2. Determine whether there are differences in self-management behaviors (medication adherence, diet, exercise, self-monitoring BP) between the two groups. 3. Examine whether self-efficacy, decision-making, motivation, patient activation, and perceived stress, and positive emotions mediate the relationship between the interventions and self-management behaviors. 4. Determine if social support, demographics (age, gender, education), discrimination, and technology utilization moderate self-management behaviors, BP, HRQoL, and psychological health. 5. Explore differences in neural processing (diffusion tensor imaging \[DTI\]/ task positive network \[TPN\] task-differentiation), and stress response (cortisol and inflammation panel) between the two groups.

COMPLETED
The Effect of Acute Mild Dehydration on Blood Pressure Control
Description

The goal of this project is determine how acute mild dehydration impacts blood pressure control at rest and during static exercise. This protocol will test healthy young and older adults in a normally hydrated and dehydrated condition.

COMPLETED
Implementation of Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control (IMPACTS)
Description

The IMPACTS study utilizes an effectiveness-implementation hybrid type 2 design to achieve two primary goals simultaneously: 1). to test the effectiveness of a multifaceted implementation strategy for intensive BP control among underserved hypertensive patients at high risk for CVD, and 2). to assess the implementation outcomes of the multifaceted implementation strategy in patients and providers.

ACTIVE_NOT_RECRUITING
COmmuNity-engaged SimULation Training for Blood Pressure Control
Description

The goal of CONSULT-BP is to train early-stage healthcare providers, including residents and nurse practitioner (NP) students, to mitigate providers' bias, improve communication skills, and enhance providers' ability to develop authentic and meaningful therapeutic alliances with patients. The study setting is an academic safety net hospital that serves a large non-White and poor population. We hypothesize that patients' outcomes (blood pressure levels) will be lower after the training intervention compared with before training (control) periods.

Conditions
COMPLETED
MI-BP: mHealth to Improve Blood Pressure Control
Description

This study seeks to evaluate a multicomponent mobile intervention to change multiple hypertension-related health behaviors in minorities and the underserved with uncontrolled hypertension. Half of the participants will receive a mobile intervention designed to improve physical activity, sodium intake, and medication adherence. The other half will receive usual care.

Conditions
COMPLETED
Effect of Acetaminophen on Postpartum Blood Pressure Control in Preeclampsia With Severe Features
Description

NSAIDs, specifically cyclo-oxygenase (COX) inhibitors, are known to increase blood pressure over time in non-pregnant adults, but the effect of COX-inhibitors on blood pressure in the setting of preeclampsia have not been well studied. This study aims to assess the effect of avoiding COX-inhibitors on postpartum blood pressure control among women diagnosed with preeclampsia with severe features. Eligible women will be randomized to receive either acetaminophen or ibuprofen for postpartum pain control. Both agents are first line therapies for pain control although ibuprofen has better pain control than acetaminophen. The primary outcome will be duration of postpartum severe-range hypertension.

COMPLETED
Southeastern Collaboration to Improve Blood Pressure Control
Description

The central objective of this proposal is to rigorously compare two strategies designed to improve BP control in primary care practices serving rural Southeastern African Americans with low socioeconomic status (SES) living in the "Black Belt". In year 1, we're engaging community members (community members who have experience being community peer advisors or have high blood pressure) to develop the study interventions and protocols. In years 2-5, the investigators will test the interventions. Year 2-5, Aim 3: Enroll 80 practices and 25 African American patients with uncontrolled HTN at each practice (total n=2000) in a cluster-randomized, controlled, 4-arm pragmatic implementation trial to evaluate the three multi- component, multi-level functional interventions finalized in the UH2 phase compared with enhanced usual care. The study's 4 arms are: 1. Enhanced Usual Care: Practices are provided with educational materials and tools to enhance patient care 2. Peer Coaching: Patients enrolled in these practices will be matched with a peer coach. The peer coach helps the patient to set goals around self-management, including medications, home monitoring, and diet and exercise, and she helps the patient to strategize how to accomplish the goals, using motivational interviewing techniques 3. Practice Facilitation: Practices randomized to this arm will work with a practice facilitator. Practice facilitation is a highly customized, staged approach to helping a practice to implement process and structural changes to enhance the quality of care and improve patient and staff satisfaction 4. Peer coaching and practice facilitation: Practices randomized to this arm will receive both the peer coach intervention and the practice facilitation intervention. Practice facilitators and peer coaches will receive the same training for this hybrid intervention, but the practice facilitator change packet will add examples of activities that integrate peer coaches.

Conditions
COMPLETED
OPTImizing Precision of Hypertension Care to Maximize Blood Pressure Control Pilot (OPTI-BP Pilot)
Description

Hypertension (HTN) is a major risk factor for coronary heart disease (CHD), heart failure, kidney failure and stroke. Disparities in HTN prevalence, treatment and control in the US have persisted for decades. The prevalence of HTN is 44% among Blacks, which is among the highest rates in the world. Those in ethnic/racial, rural, socioeconomically disadvantaged and other medically underserved populations are known to have the worst blood pressure (BP) control. Awareness of, treatment for, and control of HTN is not optimal, and varies according to race, whereby BP is controlled in \~53% of non-Latino Whites, 42% of non-Latino Blacks and only 34% of Latinos. Fundamental underlying differences in the pathophysiology contribute to HTN among different race groups. The United States (US) 2014 HTN recommendations outline race-based pharmacotherapy care for HTN. However, these recommendations use race-based population assumptions for Whites and Blacks only, do not include Latino ethnicity and have no accompanying guidelines or tools for successful implementation, particularly in rural primary care practices where disparate populations are common. Moreover, these recommendations only apply to initial therapy and lack guidance on subsequent regimen selection. The Optimizing Precision of HTN Care to Maximize BP Control Pilot (OPTI-BP Pilot), will directly address a long known and growing health disparity concern in the US which includes higher rates of death from CHD and stroke among Blacks and the poorest rates of HTN control among Latinos. Utilizing a mixed methods approach, the overarching goal of OPTI-BP Pilot is to test, using a pragmatic trial design, a personalized, algorithmic-based HTN management approach focused on age, race, biomarker (plasma renin activity) and treatment factors. The investigators hypothesize that implementation of a precision-based approach to the care of HTN in the community will improve BP reduction and ultimately reduce risk for CHD, stroke and death among those most affected by HTN.OPTI-BP Pilot is significant because it will utilize an innovative, systematic, precision-focused HTN management approach in an underserved, diverse population where BP control is currently suboptimal and lays the infrastructure groundwork for broad implementation across all areas of the US to minimize HTN related disparities and improve HTN outcomes.

COMPLETED
Text Messages and Blood Pressure Control
Description

Hypertension remains one of the most important preventable contributors to disease and death. It is the most common risk factor for strokes and myocardial infarctions in the U.S., and is associated with the greatest attributable risk for mortality among all modifiable risk factors for cardiovascular events. Over 50 million people are living with hypertension in the United States, and hypertension is one of the most common reasons for visits to a healthcare provider. Abundant evidence from randomized controlled trials has shown benefit of antihypertensive drug treatment in reducing important health outcomes in persons with hypertension. Yet, approximately 20% of U.S. adults are unaware that they have the disease. Hypertension is more difficult to diagnose than other common medical illnesses. In most cases, hypertension is asymptomatic; and accordingly patients do not seek care for it as they do for other common symptomatic illness. Patients are frequently diagnosed after presenting with end organ disease (e.g., myocardial infarctions, congestive heart failure, strokes, or renal failure). Another complicating aspect related to diagnosing uncontrolled hypertension is that multiple blood pressure measurements are needed to establish a diagnosis. Blood pressure readings can be falsely elevated in clinic due to the presence of an observer or the clinical surrounding (e.g., white coat hypertension). Even if an elevated blood pressure reading is identified in a clinic setting, more readings are needed in order to make it possible for physicians to decide about the next appropriate medical intervention. This need for multiple BP measurements over time often delays both initiating and modifying medical therapy for uncontrolled hypertension. Having patients take their BP at home facilitates the more timely diagnosis of uncontrolled hypertension by reducing diagnostic uncertainty. In fact, home measurements are better diagnostic indicators of stroke and cardiovascular mortality than clinic readings, are more closely correlated with end-organ damage, and are cost effective and well-tolerated by patients. Patients are frequently asked to record their BP after clinic visits. Historically, patients used a hand-written log, but more recently, patients are instructed to use an Internet-based web portal that uploads values to the patient's electronic medical record. Compliance with either approach relies on effective patient and provider followup, and in many settings, nurses or pharmacists will need to call patients to prompt them for their blood pressure measurements, which is both a costly and time consuming approach. Therefore, researchers need to develop effective, yet low cost alternatives to monitoring home blood pressure. This study proposes such a solution. The purpose of this study is to evaluate a simple m-health intervention to increase the ease and efficacy of diagnosing uncontrolled hypertension and achieve better blood pressure control in hypertensive patients.

Conditions
COMPLETED
Minding GOALS: An Internet-Assisted Mind-Body-Behavior Program for Blood Pressure Control
Description

This pilot study will evaluate the feasibility of adding an online mind-body-behavior program to an existing behavioral self-management support platform that has been modified to promote achievement of blood pressure goals.

Conditions
TERMINATED
Assessing Alternative Approaches for Blood Pressure Control: A3BC Trial
Description

An estimated 76 million adults in the United States over the age of 20 have hypertension (HTN); which translates into 1 out of 3 adults. Globally the prevalence of HTN is over 25% for adults, and accounts for approximately 13.5% of all deaths. Given the aging of the population together with increases in obesity and sedentary behavior, it is not surprising that HTN is projected to increase significantly over the next several decades; with over 1.5 billion adults having HTN by the year 2025. Thus the public health implications to preventing and/or reducing elevations in blood pressure are substantial. This study compares the efficacy of two different non-pharmacologic interventions (device guided breathing and isometric hand grip exercises) used alone and in combination for lowering blood pressure. This pilot study will include 30 adults with stage 1 hypertension. The primary outcome is the change in blood pressure from baseline to 8 weeks. Secondary outcomes include change in blood pressure from 8 weeks to 16 weeks and acceptability of the interventions by participants. The knowledge gained from this study can provide information on non-pharmacologic methods that may be useful in decreasing blood pressure. Such knowledge may be especially useful for patients for whom access to medications and health care is limited and among patients unwilling to take or intolerant to pharmacologic therapies.

Conditions
COMPLETED
Achieving Blood Pressure Control Through Enhanced Discharge
Description

The primary aim of the study is to determine if enhanced discharge from the emergency department will improve blood pressure control and self-care management. Enhanced discharge will include a hypertension intervention delivered by a touch-screen kiosk over a three month period.

Conditions
COMPLETED
Achieving Blood Pressure Control Together Study
Description

African Americans represent a particularly vulnerable subgroup of persons with hypertension, as they are more likely than Whites to have hypertension, equally as likely to be aware of it and to be treated for it, but less likely to achieve blood pressure control while receiving treatment. African Americans are also more likely than Whites to suffer end organ damage as a result of hypertension. Patients' hypertension self-management behaviors (including adherence to prescribed care, self-blood pressure monitoring, lifestyle changes, and shared medical decision-making) represent a cornerstone of hypertension therapy. Evidence suggests some African Americans with hypertension may experience difficulties carrying out positive self-management behaviors, in part due to cultural beliefs and practices, knowledge and perceptions regarding the nature and consequences hypertension, and lack of systems to support ongoing engagement in prescribed care within their communities. Substantial evidence has demonstrated the important role of family and community support in improving patients' management of a variety of chronic illnesses. The goal of this study is to rigorously test the effectiveness of hypertension self-management interventions that engage African American patients, their families, and their community-level resources to improve African American patients' blood pressure. We hypothesize patients' hypertension control rates may be improved when combining community health worker self-management support with other types of hypertension self-management skills training.

Conditions
TERMINATED
Premature Ventricular Contractions (PVCs) and Blood Pressure Control
Description

The purpose of this study is to determine if reduction in premature ventricular contraction (PVC) burden results in a decrease in blood pressure, sympathetic outflow, plasma catecholamines and an improvement in baroreflex gain. Flecainide will be used for PVC suppression in a randomized, double-blinded, crossover fashion.

TERMINATED
Do Home Monitors Improve Blood Pressure Control?
Description

The purpose of this study is to determine if home blood pressure monitors can help decrease blood pressure in patients with diabetes at a low income clinic.

WITHDRAWN
Pre and or Post Operative Blood Pressure Control With Clevidipine (Cleviprexm Medicines Company) in Aortic Aneurysm / Dissection
Description

2. Purpose of the Study - 1. To determine the feasibility of Clevidipine use for rapidly achieving and maintaining individually specified patient BP target ranges in the pre and postoperative periods of aortic aneurysm and dissection management. 2. To determine the safety of Clevidipine use in the pre and postoperative periods of aneurysm and dissection management 3. Background \& Significance - Surgical treatments for persons with aortic root/arch dissection or aneurysm have significantly improved survival. However, critical in management of these patients is precise control of blood pressure (BP). With increasing BP, both acute and chronic, the risk of fatal and nonfatal vascular complications is imminent. Similarly, with excessive lowering of arterial pressures, cerebral, spinal cord, cardiac, and renal ischemic hypoperfusion is also noteworthy. Typically, the target systolic blood pressure range for these patients is 100-120 mmHg. Several different classes of vasoactive agents are in current use to acutely manage BP but none possess the optimal profile of an ideal vasodilator. Notable limitations include inadequate potency, slow onset and offset of action, multiple receptor function, safety concerns and, importantly, restricted/ineffective titration, which results in clinically significant hemodynamic and cardiovascular perturbations. Recently, the ultra short-acting intravenous dihydropyridine calcium-channel blocker clevidipine (Cleviprex, The Medicines Company) was approved for management of BP in critical care settings. Clevidipine's pharmacology lends itself to acute management of BP in a broad critical care setting in both surgical and nonsurgical patients. In the current study, the investigators propose to further characterize the hemodynamic effect of CLV in the pre and post-operative management of BP in patients with aortic aneurysm/dissection. 4. Design \& Procedures Eligible patients will be approached to participate in the study by the Intensive Care Unit (ICU) attending and/or by a cardiothoracic surgical/anesthesiology fellow or a cardiac research nurse. All aspects of clinical management and monitoring will be according to standard practice that includes: * ECG * Oxymetry * Temperature * Invasive arterial blood pressure * Recording of routine laboratory results * Imaging studies including CT/MRI (A)/ Echocardiography * Pulmonary artery catheter (postoperative patients) * Mechanical ventilation (postoperative patients) * According to established protocol for acute intravenous management of arterial blood pressure in these patients, an upper and lower threshold of systolic blood pressure will be prescribed by the attending physician (the range being (100 mmHg -120 mm Hg SBP). Hemodynamic data will be collected continuously via a bedside laptop as well as pertinent clinical data and information about efficacy and safety will be recorded. • Subjective evaluation of efficacy of CLV (questionnaire format to be completed by the critical care team)

COMPLETED
Pilot Study of Home Blood Pressure Control Program (eBP Control)
Description

This intervention study will evaluate the feasibility,acceptability and effectiveness of an e-health enabled model of care by randomly assigning a trained patient navigator and/or a blood pressure (BP) self-management web portal to patients with uncontrolled hypertension after a run in period with a home BP monitor (HBPM) and comparing the results on blood pressure control. We anticipate that patients receiving the combination of a patient navigator(PN)with a self-management web portal and home BP monitor will have better BP control than when the only received a home BP monitor.

COMPLETED
Esmolol or Nitroglycerin Infusion for Blood Pressure Control Prior to Cardiopulmonary Bypass (CPB) in Cardiac Surgery
Description

This is an investigator initiated, sponsored, open label, prospective randomized controlled trial to be performed in adult patients undergoing scheduled cardiac surgery. Patients will be randomized to esmolol infusion or nitroglycerin infusion for control of hypertension that occurs during cardiac surgery from induction of anesthesia to initiation of cardiopulmonary bypass (CPB).

Conditions